Risperidone - Generic Drug Details

What are the generic sources for risperidone and what is the scope of freedom to operate?

Risperidone is the generic ingredient in seven branded drugs marketed by Labs Farms Rovi Sa, Shandong Luye, Indivior, Janssen Pharms, Amneal, Nanomi, Teva Pharms Usa Inc, Amneal Pharms, Ani Pharms, Apozeal Pharms, Aurobindo Pharma Ltd, Chartwell Molecular, Hikma, Lannett Co Inc, Pharm Assoc, Precision Dose, Sun Pharma Canada, Tris Pharma Inc, Wockhardt Bio Ag, Teva, Actavis Labs Fl Inc, Anda Repository, Chartwell Rx, Dash Pharms, Jubilant Generics, Ph Health, Sandoz, Sun Pharm Inds Ltd, Zydus Pharms Usa, Ajanta Pharma Ltd, Apotex Inc, Dr Reddys Labs Ltd, Heritage Pharma Avet, Ipca Labs Ltd, Jubilant Cadista, Novitium Pharma, Prinston Inc, Ratiopharm, Renata, Rising, Sun Pharm Inds Inc, Synthon Pharms, Torrent Pharms, Watson Labs, West Ward Pharms, and Zydus Pharms Usa Inc, and is included in fifty-six NDAs. There are forty-one patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Risperidone has three hundred and sixty-one patent family members in forty-three countries.

There are thirty drug master file entries for risperidone. Forty suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for risperidone

International Patents:	361
US Patents:	41
Tradenames:	7
Applicants:	46
NDAs:	56
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	40
Raw Ingredient (Bulk) Api Vendors:	143
Clinical Trials:	572
Drug Prices:	Drug price trends for risperidone
Drug Sales Revenues:	Drug sales revenues for risperidone
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for risperidone
What excipients (inactive ingredients) are in risperidone?	risperidone excipients list
DailyMed Link:	risperidone at DailyMed

See drug prices for risperidone

See drug sales revenues for risperidone

Recent Clinical Trials for risperidone

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University Hospital, Strasbourg, France	PHASE2
National Institute of Mental Health (NIMH)	PHASE4
Northwell Health	PHASE4

See all risperidone clinical trials

Generic filers with tentative approvals for RISPERIDONE

Applicant	Application No.	Strength	Dosage Form
		1MG/ML	SOLUTION; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for risperidone

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for risperidone

Antipsychotic Agents

Dopamine Antagonists

Serotonin Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for risperidone

N05AX	Other antipsychotics
N05A	ANTIPSYCHOTICS
N05	PSYCHOLEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for RISPERIDONE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RISPERDAL	Orally Disintegrating Tablets	risperidone	0.25 mg	021444	1	2005-04-11
RISPERDAL	Orally Disintegrating Tablets	risperidone	3 mg and 4 mg	021444	1	2005-03-23

US Patents and Regulatory Information for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Jubilant Generics	RISPERIDONE	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	090839-004	Nov 4, 2011	AB	RX	No	No
Janssen Pharms	RISPERDAL	risperidone	TABLET;ORAL	020272-008	May 10, 1999	AB	RX	Yes	No
Dash Pharms	RISPERIDONE	risperidone	TABLET;ORAL	076288-005	Sep 15, 2008		DISCN	No	No
Labs Farms Rovi Sa	RISVAN	risperidone	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	214835-002	Mar 29, 2024		DISCN	Yes	No
Zydus Pharms Usa Inc	RISPERIDONE	risperidone	TABLET;ORAL	078040-001	Oct 16, 2008	AB	RX	No	No
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-001	Apr 28, 2023		RX	Yes	Yes			Y

Expired US Patents for risperidone

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-001	Oct 29, 2003
Janssen Pharms	RISPERDAL	risperidone	TABLET, ORALLY DISINTEGRATING;ORAL	021444-002	Apr 2, 2003
Janssen Pharms	RISPERDAL CONSTA	risperidone	INJECTABLE;INTRAMUSCULAR	021346-003	Oct 29, 2003
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-007	Apr 28, 2023
Teva	UZEDY	risperidone	SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS	213586-005	Apr 28, 2023

EU/EMA Drug Approvals for risperidone

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Laboratorios Farmacéuticos Rovi, S.A.	Okedi	risperidone	EMEA/H/C/005406Treatment of schizophrenia in adults for whom tolerability and effectiveness has been established with oral risperidone.	Authorised	no	no	no	2022-02-14

International Patents for risperidone

Country	Patent Number	Title	Estimated Expiration
Mexico	362874
San Marino	T202200127
Denmark	1940351
World Intellectual Property Organization (WIPO)	2005070332
New Zealand	581862	Injectable subcutaneous formulation comprising risperidone capable of forming a solid, microporous implant in a patient
Singapore	11201407961W

Supplementary Protection Certificates for risperidone

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0196132	94C0008	Belgium		PRODUCT NAME: RISPERIDONE; NAT REG.: 2 S 414 F 3 19940527; FIRST REG.: GB 0242/0186 19921208

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Risperidone

Last updated: July 27, 2025

Introduction

Risperidone, a second-generation antipsychotic medication developed by Janssen Pharmaceuticals, has established itself as a pivotal treatment option for schizophrenia, bipolar disorder, and irritability associated with autism. With a market that continues to evolve amid healthcare reforms, patent expirations, and emerging generics, understanding the current market dynamics and financial trajectory of risperidone is essential for stakeholders ranging from pharmaceutical companies to investors and healthcare providers.

This analysis explores the market landscape, key drivers, challenges, and future financial outlook for risperidone, providing nuanced insights into its strategic positioning within the pharmaceutical industry.

Market Overview and Demand Drivers

Global Market Size

The global antipsychotic drugs market, valued at approximately USD 16 billion in 2021, projected a compound annual growth rate (CAGR) of around 4% through 2028 [1]. Risperidone, accounting for a significant share, is a core product within this domain. The drug's primary indications—schizophrenia and bipolar disorder—drive sustained demand in North America, Europe, and emerging markets such as Asia-Pacific.

Clinical Efficacy and Safety Profile

Risperidone's reputation stems from its balanced efficacy and tolerability compared to first-generation antipsychotics; this has maintained its prominence in clinical practice. Its approval for multiple psychiatric conditions and formulations (oral and long-acting injectables) broaden its patient base.

Demographic and Epidemiological Factors

Increasing prevalence of schizophrenia and bipolar disorder, driven by urbanization, aging populations, and improved diagnostic criteria, sustains market demand. The World Health Organization estimates that schizophrenia affects over 20 million people globally, with treatment rates often exceeding 70% when accessible [2].

Market Dynamics: Key Drivers

Patent Expiration and Generics Competition

Risperidone's primary patent in the United States expired around 2008 for the oral formulation, leading to a surge in generic availability. However, the patent for the long-acting injectable (LAI) formulations, such as Risperdal Consta, persisted until 2018–2020. The entry of generics has significantly impacted Risperidone's market share and pricing strategies.

Pricing Pressure and Cost-Containment

Healthcare systems worldwide are under cost-containment pressures. Generics typically reduce treatment costs, leading to a decline in branded risperidone sales. However, branded formulations retain market segments, especially in regions with slower generic adoption or where physicians prefer proprietary products due to perceived efficacy or safety profiles.

Regulatory and Reimbursement Policies

Stringent regulatory approvals, varying reimbursement policies, and shifts towards value-based care influence risperidone's market penetration. Reimbursement favoring long-acting formulations in certain regions offsets some impact of generics by promoting new prescribing patterns.

Emergence of Newer Antipsychotics

The advent of third-generation antipsychotics such as aripiprazole and brexpiprazole offers alternative treatment options with potentially improved side-effect profiles. Their market share growth may cannibalize risperidone's demand in specific indications.

Innovations in Formulation and Delivery

Novel delivery systems, including depot injections with extended dosing intervals and digital adherence tools, enhance patient compliance and influence market dynamics. Janssen's development of longer-acting formulations aims to sustain competitive advantage.

Competitive Landscape

Key Players

• Janssen Pharmaceuticals: Original innovator with a diversified portfolio of risperidone formulations.
• Generics Manufacturers: Multiple players, including Teva, Sandoz, and Mylan, produce cost-effective generic equivalents widely adopted globally.
• New Entrants: Companies developing biosimilars or novel delivery methods challenge traditional formulations.

Market Share Distribution

Post-patent expiry, generics rapidly capturing market share diminished branded risperidone's dominance in developed nations. However, branded products maintain a significant presence in restricted markets and specific patient populations requiring tailored formulations.

Financial Trajectory Analysis

Revenue Trends

Following patent expiry, branded risperidone revenues in North America declined sharply, with estimates showing a 70% reduction within five years post-patent loss [3]. Nonetheless, in emerging markets, brand and generic sales continue to grow due to expanding healthcare access and high unmet needs.

Pricing and Profitability

Generic competition exerts downward pressure on unit prices. However, profit margins are preserved through volume growth, supply chain efficiencies, and higher-priced long-acting formulations. Innovation-driven premium pricing strategies are also employed in niche markets.

Research & Development Investments

Janssen's ongoing R&D efforts focus on new formulations and combination therapies, potentially creating additional revenue streams. Strategic licensing agreements for biosimilar or derivative products may influence future financial flows.

Forecasting the Future

Projections suggest that, despite generic erosion, risperidone's global revenues will stabilize around USD 1-2 billion annually through 2030, driven by emerging markets and formulation innovations [4].

Market Challenges and Opportunities

Challenges

• Market Saturation: Widespread generic adoption limits pricing power and margins.
• Regulatory Hurdles: Stringent approval pathways for new formulations and biosimilars.
• Patient Preferences: Growing demand for newer drugs with better side effect profiles.

Opportunities

• Extended-Release Formulations: Longer dosing intervals improve compliance and can command premium pricing.
• Combination Therapies: Co-formulations with other psychiatric agents present new market segments.
• Digital and Adherence Technologies: Telemedicine integrations and digital adherence tools support optimal therapy management.

Regulatory and Patent Outlook

While the original patents have lapsed, innovative formulations may qualify for new patents, securing exclusivity periods and enabling premium pricing. Regulatory pathways for biosimilars and digital health devices continue to shape competitive strategies.

Conclusion

Risperidone's market and financial landscape have undergone profound shifts driven by patent expirations, generics proliferation, and evolving treatment paradigms. Although traditional revenues declined post-patent, strategic focus on formulation innovation, emerging markets, and adjunct therapies presents growth avenues. Stakeholders must navigate complex regulatory and competitive environments to sustain profitability.

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Key Takeaways

• Patent expirations triggered a significant decline in branded risperidone sales, replaced largely by generic formulations.
• Emerging markets and long-acting injectable formulations serve as growth catalysts amid generic competition.
• Innovation in delivery systems and combination therapies offer opportunities to extend risperidone’s market relevance.
• Pricing pressures necessitate value-based strategies, emphasizing patient adherence and clinical outcomes.
• Regulatory protections through new patents for formulations can sustain revenue streams and market exclusivity.

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FAQs

1. How has patent expiration affected risperidone's market share?
Patent expiration, primarily for the oral formulation around 2008, led to a surge in generic competition, significantly reducing branded risperidone revenue and market share, especially in North America and Europe.

2. What are the primary factors influencing risperidone’s future sales?
Emerging formulations, market penetration in developing regions, competition from newer antipsychotics, and regulatory environments are key factors shaping future sales trajectories.

3. Are biosimilars impacting risperidone’s market?
Currently, biosimilars are not prevalent for risperidone, but future developments could introduce biosimilar versions, affecting pricing and market share.

4. What role does formulation innovation play in risperidone’s market strategy?
Innovations in long-acting depot injections and digital adherence tools help maintain competitive advantage and justify premium pricing despite generic pressure.

5. Which regions are expected to drive future growth for risperidone?
Emerging markets in Asia-Pacific, Latin America, and Africa, where healthcare infrastructure is expanding, are projected to underpin growth, alongside continued uptake of novel formulations globally.

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References:

[1] Grand View Research, "Antipsychotic Drugs Market Size, Share & Trends Analysis," 2022.
[2] WHO, "Schizophrenia Fact Sheet," 2021.
[3] IQVIA, "Pharmaceutical Market Trends," 2022.
[4] MarketWatch, "Global Antipsychotic Market Forecast," 2022.